Cyclopropanes

Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem

Retrieved on: 
Monday, November 30, 2020

The NDA submission includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated with no significant drug related adverse events.

Key Points: 
  • The NDA submission includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated with no significant drug related adverse events.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Salix's Methylnaltrexone Abstract Wins Best Of Meeting Award At ASRA's Annual Pain Medicine Meeting

Retrieved on: 
Thursday, November 19, 2020

"Salix is honored to be recognized by ASRA for a Best of Meeting Award, a distinction that is reserved for the highest scoring scientific abstracts.

Key Points: 
  • "Salix is honored to be recognized by ASRA for a Best of Meeting Award, a distinction that is reserved for the highest scoring scientific abstracts.
  • Our scientific poster presentation includes analyses examining the effects of subcutaneous methylnaltrexone in cancer and non-cancer patients with opioid-induced constipation,"said Howard Franklin, M.D., chief medical officer, Salix.
  • The Salix abstract will be available via the ASRA online portal beginning Nov. 21:
    Shah, Eric.
  • Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care.

QBiotics' STELFONTA® Receives FDA Approval for Canine Mast cell Tumours

Retrieved on: 
Wednesday, November 18, 2020

The efficacy and durability of response data in dogs with mast cell tumours are very promising.

Key Points: 
  • The efficacy and durability of response data in dogs with mast cell tumours are very promising.
  • While surgery will remain the mainstay, I do think STELFONTA will reshape how we approach local mast cell tumour control in many ways."
  • Dr Victoria Gordon, CEO and Managing Director of QBiotics, said, "FDA approval is a pivotal achievement for both STELFONTA and QBiotics.
  • Randomized controlled clinical study evaluating the efficacy and safety of intratumoural treatment of canine mast cell tumours with tigilanol tiglate (EBC-46).

QBiotics' STELFONTA® Receives FDA Approval for Canine Mast cell Tumours

Retrieved on: 
Wednesday, November 18, 2020

The efficacy and durability of response data in dogs with mast cell tumours are very promising.

Key Points: 
  • The efficacy and durability of response data in dogs with mast cell tumours are very promising.
  • While surgery will remain the mainstay, I do think STELFONTA will reshape how we approach local mast cell tumour control in many ways."
  • Dr Victoria Gordon, CEO and Managing Director of QBiotics, said, "FDA approval is a pivotal achievement for both STELFONTA and QBiotics.
  • Randomized controlled clinical study evaluating the efficacy and safety of intratumoural treatment of canine mast cell tumours with tigilanol tiglate (EBC-46).

BioCorRx Provides Business Update for the Third Quarter of 2020; BioCorRx Subsidiary, BioCorRx Pharmaceuticals Inc. Progressing with Pivotal Nonclinical BICX102 Study

Retrieved on: 
Monday, November 16, 2020

Lourdes vital contribution to the Company makes her the right CEO for the next chapter at BioCorRx.

Key Points: 
  • Lourdes vital contribution to the Company makes her the right CEO for the next chapter at BioCorRx.
  • In our partnership over the years, she has been a key player in defining and executing on our strategic initiatives, said Mr. Granier.
  • I am grateful and honored to serve as CEO of BioCorRx and appreciate the confidence shown by Brady and the Board of Directors, said Lourdes.
  • Our subsidiary, BioCorRx Pharmaceuticals Inc., continues to progress our pivotal good laboratory practice (GLP) preclinical studies of BICX102, a sustained release naltrexone implant for the treatment of opioid and alcohol use disorders.

IntelGenx Announces Publication of a Study Evaluating Montelukast’s Effect on Neurological Aging

Retrieved on: 
Monday, November 9, 2020

We are very encouraged that the current study, which includes additional prescription database data and results from the Troms Study, further supports Montelukasts potential to postpone mental aging.

Key Points: 
  • We are very encouraged that the current study, which includes additional prescription database data and results from the Troms Study, further supports Montelukasts potential to postpone mental aging.
  • The article, co-authored by Dr. Aigner from the Paracelsus Medical University in Salzburg, Austria, is entitled, A possible effect of montelukast on neurological aging examined by the use of register data.
  • The study used multivariate linear regression analyses to see how the use of various medications was associated with neurological health test results.
  • The study found that previous use of Montelukast correlated with improved scores on cognitive or neurological functioning, suggesting that Montelukast may alleviate degenerative neurological changes associated with human aging.

BRILINTA Approved in the US to Reduce the Risk of Stroke in Patients With an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Retrieved on: 
Friday, November 6, 2020

BRILINTA is a well-established medicine across patients with coronary artery disease and with todays approval, we can now expand its potential to patients with an acute ischemic stroke or transient ischemic attack.

Key Points: 
  • BRILINTA is a well-established medicine across patients with coronary artery disease and with todays approval, we can now expand its potential to patients with an acute ischemic stroke or transient ischemic attack.
  • The risk for severe bleeding events was 0.5% in patients receiving aspirin plus BRILINTA and 0.1% for aspirin alone.
  • BRILINTA is indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction.
  • Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services.

Exelixis Announces Third Quarter 2020 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 5, 2020

Based upon cabozantinib-related revenues generated by Exelixis collaboration partner Ipsen in the third quarter of 2020, Exelixis earned $19.9 million in royalty revenues.

Key Points: 
  • Based upon cabozantinib-related revenues generated by Exelixis collaboration partner Ipsen in the third quarter of 2020, Exelixis earned $19.9 million in royalty revenues.
  • Presentation of Positive Results from CheckMate -9ER Phase 3 Pivotal Trial during Presidential Symposium I at the European Society for Medical Oncology Virtual Congress 2020 (ESMO 2020).
  • In September 2020, Exelixis presented positive phase 1b clinical trial results for the combination of cabozantinib and atezolizumab in patients with locally advanced or metastatic solid tumors at ESMO 2020.
  • Exelixis management will discuss the companys financial results for the third quarter of 2020 and provide a general business update during a conference call beginning at 5:00 p.m. EST / 2:00 p.m. PST today, Thursday, November 5, 2020.

Arcutis Biotherapeutics Presents New Positive Data from Phase 2 Studies of ARQ-151 (Topical Roflumilast Cream) in Chronic Plaque Psoriasis and Atopic Dermatitis

Retrieved on: 
Monday, November 2, 2020

Roflumilast cream, a potent phosphodiesterase-4 (PDE-4) inhibitor, is being investigated as a once-daily topical treatment for chronic plaque psoriasis and atopic dermatitis.

Key Points: 
  • Roflumilast cream, a potent phosphodiesterase-4 (PDE-4) inhibitor, is being investigated as a once-daily topical treatment for chronic plaque psoriasis and atopic dermatitis.
  • The results from our Phase 2 studies highlight the potential of roflumilast cream as a best-in-class topical PDE4 inhibitor for chronic plaque psoriasis and atopic dermatitis, said Patrick Burnett , M.D., Ph.D., FAAD, Arcutis Chief Medical Officer.
  • The Phase 2b psoriasis study data provide clinical evidence of roflumilast creams ability to reduce the burden of itch and improve typical symptoms in patients with plaque psoriasis.
  • In the Phase 2b study, 331 patients were randomized to roflumilast 0.3% (n=109), roflumilast 0.15% (n=113), or vehicle (n=109).

Information update - LEO Pharma Inc. is withdrawing the drug Picato (Ingenol mebutate), used to treat skin lesions, due to the potential increased risk of skin cancer

Retrieved on: 
Tuesday, October 27, 2020

What to do: Stop your treatment and talk to your healthcare professional about other treatment options.

Key Points: 
  • What to do: Stop your treatment and talk to your healthcare professional about other treatment options.
  • Monitor your skin for signs or symptoms of skin cancer.
  • At Health Canada's request, LEO Pharma Inc. is withdrawing Picato from the Canadian market.
  • On October 26, 2020, LEO Pharma Inc. initiated the recall of Picato from the Canadian market.